Concept Modeling should be used as an opportunity for cross-project review of modeling approaches, to minimize inconsistencies. Once concept modeling has been completed, a set of information requirements will be developed. It is useful at this point to incorporate sample data to show how concepts are mapped. To understand what the data requirements are, CRFs or sample datasets can be reviewed. Using the User Guide Template, explanatory text (bulleted lists of data and metadata) for specific concepts can now be included in the Draft Standards Product.
A risk assessment should be done before submitting terminology dependent on new modeling structures. The assessment determines if a concept is well-defined, clearly understood, and can be unambiguously placed in existing CDISC foundational standards. If a concept does not meet these requirements, then it is advised that SDTM experts be consulted. Any new terminology needed that fits within existing SDTM structures, such as clinical responses, qualifiers, anatomical locations, methods and other information, should be submitted via the Terminology Development Process. Terminology and Questionnaires have their own teams and development processes outside the Standards Development Process. The Team Lead/Project Manager should periodically check progress of these parallel processes, i.e. check with the Terminology and Questionnaire Team Leads to ensure the needed terms and questionnaires are available within the timeline of the project.
If significant SDTM issues have not been resolved within the timeline of the project, or it is expected that new SDTM variables will not be ready for inclusion in the version of the document under development, this should be noted in the Standards Product under the “Known Issues” section.
It is important to obtain input from regulatory experts. Input received from these experts should be acknowledged and carefully managed. If input from a FDA Liaison is not carried through in the document, the Team Lead/Project Manager should directly communicate the decision (and motivations) to the commenter. The Clinical Expert should assist in this communication. The FDA Liaison should be asked to acknowledge this communication.